Identity
- Trade Name
- Ena Bond ® FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- Name: Ena Bond Model: Catalyst/Light curing bonding EUDAMEDENA-BOND BI COMPONENT INTRO KIT Etch & Rinse Two-Component Bonding System 1 COSM300A Ena Bond Light Curing Primer (5 ml) 1 COSZ10 Ena Seal Light Curing Resin (5 ml) 1 COS101 Ena Etch 37% (2 ml) + Applicators, mixing pad, tips FDA UDI
- Model / Reference
- COSM300K EUDAMEDFDA UDI
- Description
- ENA-BOND BI COMPONENT INTRO KIT Etch & Rinse Two-Component Bonding System 1 COSM300A Ena Bond Light Curing Primer (5 ml) 1 COSZ10 Ena Seal Light Curing Resin (5 ml) 1 COS101 Ena Etch 37% (2 ml) + Applicators, mixing pad, tips FDA UDI
Identifiers
- Catalog Number
- COSM300K FDA UDI
- Primary DI / UDI-DI
- EMICCOSM300K1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EMICFAM1AV7 EUDAMED
- 510(k) Number
- K072978 FDA UDI
- FDA Product Code
- DYH FDA UDI
- EMDN Code
- Q01010104 DENTAL BONDING AGENTS EUDAMED
- GMDN Term
- Dentine bonding agent/set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3750 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 12 Milliliter FDA UDI
Category: Dentine bonding agent/set
Ena Bond ® by Micerium Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dentine bonding agent/set.
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
Cleared under the same submission
K072978 also covers:
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micerium Spa
Sources (2)
- FDA UDI fc423ec0-8e89-4ab2-8bb7-44f9b224f6eb 37 fields · synced Jul 21, 2026
- EUDAMED 9e40969a-898c-4aab-8e51-b4af57b4c23a 61 fields · synced Jul 21, 2026